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Csv consultant

Cork
BioTalent
Consultant
Posted: 31 January
Offer description

We are seeking an experienced CSV Senior Consultant with a strong background in pharmaceutical automation systems to support multiple automation upgrade projects at our Cork manufacturing site. The consultant will play a critical role in ensuring compliant validation of upgraded HMI and PLC systems in a regulated GMP environment.Key ResponsibilitiesLead and execute Computer System Validation (CSV) activities for automation upgrade projects involving HMI and PLC systems.Support 2–3 site-based automation upgrades, including system lifecycle documentation (URS, FRS, IQ/OQ/PQ, RTM).Ensure all validation activities comply with GxP, FDA, EMA, and 21 CFR Part 11 requirements.Collaborate closely with Automation, Engineering, Quality, and IT stakeholders to support successful project delivery.Participate in and support validation activities during the summer shutdown period (no planned leave during this time).Provide on-site support at the Cork facility in line with the hybrid working model.Required Qualifications & Experience5–10 years of CSV experience within the pharmaceutical or life sciences industry.Proven hands-on experience validating automation systems, including Siemens PLCs and HMIs.Strong knowledge of GMP-regulated manufacturing environments.Experience supporting automation upgrades and remediation projects.Solid understanding of CSV lifecycle methodologies and regulatory expectations.Ability to work independently and manage multiple workstreams.Additional RequirementsImmediate availability or short notice preferred.Willingness to work on-site in Cork 3 days per week.Availability to support critical activities during the summer shutdown period.Prior experience working on site-wide automation upgrades in pharmaceutical manufacturing.Familiarity with data integrity requirements and risk-based validation approaches.

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